What Pradaxa Patients Need to Know about Bleeding Risks By Tod Aronovitz | 05/02/13 | 0 Comment

Pradaxa (dabigatran), a blood-thinning agent commonly prescribed for reducing the risk of stroke, may cause severe internal bleeding and serious injury, according to recent studies and disclosures by Pradaxa manufacturer Boehringer Ingelheim. Although other anti-coagulants such as Coumadin or Jantoven (warfarin) may carry the same bleeding risks, Pradaxa currently does not have an antidote to stop the bleeding, unlike the other blood-thinners.

After being approved for consumers in October 2010, Pradaxa has been traditionally given to patients who are particularly prone to having a stroke due to abnormal heart rhythm. After one year on the market, the FDA was notified of 542 deaths attributed to the use of Pradaxa. In addition, drug trials have found that 16.6% of users may experience bleeding, and that risk increases for patients 75 years and older.

The FDA also received reports of an additional 3,781 men and women who experienced adverse side effects while on Pradaxa, including severe, life-threatening and even life-ending internal bleeding.  In some cases, the internal bleeding could not be stemmed even when the patient was taken off the drug.

Common symptoms of Pradaxa internal bleeding include but are not limited to:

  • External bleeding through mouth or nose
  • Bruising (not attributable to any external cause)
  • Coughing up blood
  • Brown or pink tint to urine
  • Joint pain and/or joint swelling
  • Vomiting (producing a consistency of coffee grounds)
  • Headaches
  • Dizziness
  • Weakness
  • Other effects: cerebral hemorrhaging, internal bleeding and ulcers

The FDA evaluated this new information late last year and found that bleeding rates associated with new use of Pradaxa do not appear to be higher than bleeding rates associated with new use of warfarin, according to insurance claim and administrative data from the agency’s Mini-Sentinel pilot of the Sentinel Initiative. The FDA is continuing to evaluate multiple sources in the ongoing safety review, but has not changed its recommendations regarding Pradaxa because the drug provides an important health benefit when used as directed.

On April 30, Boehringer Ingelheim announced three important updates to the U.S. prescribing information for Pradaxa:

1.)    The Pradaxa label now carries a Boxed Warning, similar to the Boxed Warnings in the labels of other new OACs, to advise patients that discontinuing treatment puts them at increased risk of stroke. A similar warning was previously stated in the Pradaxa Prescribing Information (sections 5.3 and 17.1) and Medication Guide.

2.)    The postmarketing experience section of the Pradaxa label has been updated to include thrombocytopenia.

3.)    The Pradaxa label now includes data from the pivotal RE-LY® trial that showed a lower rate of all-cause death with Pradaxa 150 mg than warfarin (3.6 percent per year versus 4.1 percent per year). The rate of vascular death was lower on Pradaxa compared to warfarin (2.3 percent per year versus 2.7 percent per year). Non-vascular death rates were similar in the treatment arms.

“Patient safety is our top priority at Boehringer Ingelheim,” said Sabine Luik, M.D., senior vice president, medicine & regulatory affairs, U.S. regional medical director, Boehringer Ingelheim Pharmaceuticals, Inc. “We have worked closely with the FDA to reinforce the importance of adhering to Pradaxa to reduce the risk of stroke through this updated label. Patients should not stop taking Pradaxa unless directed by a physician.”

Healthcare professionals who prescribe Pradaxa should carefully follow the dosing recommendations in the drug label. Patients should not stop taking Pradaxa without talking to their health care professionals first.

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